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Dairy Facts 2016

FDA Proposes Gluten Free Requirements for Fermented Foods

Nov 24, 2015

Last week, the Food and Drug Administration (FDA) proposed a process for how fermented and hydrolyzed foods, including yogurt and cheeses, would qualify for a “gluten free” label claim. This follows up on regulations defining gluten free claims that went into effect in 2014.

Because there are uncertainties with results from the analytical methods used for testing gluten content in fermented and hydrolyzed products, a different procedure was needed to ensure that gluten-free claims would be useful for patients with celiac disease, who must avoid consuming gluten. The proposal indicates that to make such a claim, companies would need to prove that the product prior to fermentation or hydrolysis meets the definition of gluten free. Then the product would need to be protected from cross contact that could introduce gluten into the product. Companies would need to provide records to FDA that prove the truthfulness of their claims.

In addition to asking for input on the proposal for demonstrating compliance with the “gluten free” claim, FDA also asked for input on the process that could be used to meet “gluten free” claims for fermented or hydrolyzed foods that have been dried or concentrated. Since these products would have the same issues with interpretation of test results, but could have more concentrated levels of gluten, these may require a different approach.

While this is a proposed rule, depending on the content of a final rule, yogurt and cheese companies may need to update their practices on how they prove compliance with the requirements for the claim. Depending on the product, companies would need to supply data or records to prove that the product prior to fermentation is gluten free, and demonstrate there is no cross-contact with gluten-containing ingredients. FDA has proposed an effective date of one year following the publication of a final rule.

Comments on the proposed rule are due by February 16, 2016. To learn more, read the proposed rule here, or contact Michelle Matto, IDFA’s nutrition and labeling consultant, at

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